FDA Auditing Consultants

If your company does not understand the FDA inspection process, you are likely to be unprepared. Our consultants help you:
  • Respond to FDA Warning Letters
  • Prepare for FDA Routine Inspections
  • Get ready for a Pre-Approval Inspection
  • Prepare for an FDA For-Cause Inspection
  • Perform Due Diligence CGMP reviews for mergers/acquisitions
For more information on these services, visit our page on FDA Audit Services.

Compliance with FDA Submission Requirements

We help domestic and foreign companies comply with US FDA regulations. Our executive team has held high-level positions at FDA. We can
  • Evaluate the regulatory status of your ingredient/product
  • Assist with GRAS notifications, FCNs or NDI submissions
  • Help with Drug submissions (ANDAs, INDs & NDAs)
  • Assist with Medical Device Submissions (PMAs, IDEs and 501ks)
  • For more information, visit our page on FDA Submission Services.

Expert Help for FDA Registration and Listing

Our team of experts can:
  • Serve as your US FDA Agent
  • Register your domestic or foreign facility with the FDA
  • Update your registration information when changes occur
  • Confirm to your customers (at your request) that you have registered your facility with FDA
  • Assist with import problems
For more information, visit our page on FDA Registration and Listing Services.